Six-person ALS biotech wants to go public — but it’s also pivoting from earlier plans

21 Nov 2022
endpts.com
Phase 2Cell TherapyPhase 1Clinical ResultIPO
With an S-1 filing with the SEC on Friday, regulatory T cell operation Coya Therapeutics foreshadowed its plans to get on Nasdaq. At six full-time employees, the biotech out of Houston would make for a tiny public company.
The move comes at a time when IPOs in biotech are scarce, as the bear market continues to batter the industry. In November, Acrivon Therapeutics was the lone biotech to make the bold jump while others like Artiva, Elicio and Emalex backed away from the public market.
Coya’s one clinical candidate is a regulatory T cell, or Treg, therapy for ALS. The therapy, dubbed COYA 101, is made out of a patient’s own T cells, which are then engineered and given back to the patients through an IV. The idea behind the therapy is that the regulatory T cells would reduce neuroinflammation associated with ALS, thereby slowing the breakdown of motor neurons.
In a small Phase IIa study completed in May of last year, the patients who got Coya’s therapy saw more Treg function than those in the placebo group. But when it came to comparing clinical outcomes — scores on the ALS functional rating scale — researchers said “a meaningful evaluation of progression rates in the RCT between the placebo and active groups was not possible due to the limited number of enrolled participants aggravated by the COVID-19 pandemic.”
In the open-label portion of the study, Coya said six of eight patients saw slowed progression, with functional scale scores decreasing by an average of 2.7 points over 24 weeks, though there was variation from patient to patient (and one patient contracted Covid), while two others saw their functional scale scores decrease by 11 and 10 points.
Coya declined to comment for this story. In June of this year, the biotech raised $10.3 million, which it said it would use toward putting COYA 101 in a Phase IIb study, as well as starting Phase I studies for its other Treg therapies, including another one for ALS and one for dementia.
But now Coya appears to be pivoting away from those plans. According to the S-1, Coya plans to push forward its other preclinical candidates before running further clinical trials on COYA 101. It said:
We currently believe we are best served by utilizing our available cash to advance each of COYA 301, COYA 302, COYA 201 and COYA 206 before commencing a Phase 2b clinical trial of COYA 101. The costs associated with such a Phase 2b trial would significantly impede our ability to advance COYA 301, COYA 302, COYA 201 and COYA 206 before we can reasonably judge which product candidates and which therapeutic modalities may have the most potential.
And on COYA 101, it hopes instead to get other funding to push it forward — either in the form of grant money or a partnership. In the S-1, it projected that the Phase IIb trial would now come in 2024.
The biotech started when AbbVie vet, now Coya CEO, Howard Berman took interest in Houston Methodist Hospital’s Stan Appel’s Treg research, licensing it in October of 2020. Including a $10 million Series A from February of 2021, the biotech has raised just over $20 million. And of that, it has spent some $14.8 million as of the end of September.
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